Risks and Warnings for Aristada (Aripiprazole lauroxil)

Older patients with dementia-related psychosis have a higher risk of stroke and sudden death when treated with antipsychotic medications. People over 65 with this condition should not be taking this medicine.

This is a black box warning. The FDA requires this warning when there is a significant risk of serious or life-threatening effects that anyone taking the drug should consider.

Means that some groups have a high risk of experiencing this side effect